Project Description

GENTAFIX® 1&3

Surgical Cement with Antibiotic

GENTAFIX® 1&3 are radiopaque and self-hardening bone cements
• Containing Gentamicin, an aminoglycoside antibiotic
• Dedicated to arthroplasty surgery
• Allowing immediate and stable anchorage of implants
• Responding to the needs of surgeons, 2 viscosities for 2 types of applications:

GENTAFIX® 1: high viscosity bone cement for manual application

GENTAFIX® 3: low viscosity bone cement with an optimum fluidity for an easy application with syringe or injection gun

ADVANTAGES

  • Mechanical properties above ISO 5833 standard
  • Low exothermicity in situ
  • Low release of monomer
  • Stable fixation of implants
  • Suitable viscosity
  • Barium sulfate as excellent radiopaque agent
  • Easy to prepare with a bowl & spatula or in a vacuum mixing system

GENTAFIX® bone cements are intended for use in cemented arthroplasty procedures.

  • GENTAFIX® 1 is indicated for primary (shoulder, hip, knee) and revision (knee) surgeries.
  • GENTAFIX® 3 is indicated for primary (hip) and revision (hip, knee) surgeries.

GENTAFIX® bone cements allow local antibiotherapy.

Gentamicin, issued from family of aminosides, has abroad spectrum and is effective against most of the bacteria encountered.
The quantity of gentamicin contained in one dose of cement has been optimized to guarantee a long term release to cure or prevent infections.

Designation References
BOWL & SPATULA KIT pack of 10u
non sterile		 T060404
VACUUKIT® Vacuum mixing & Injection system T060416

References

Designation Reference
GENTAFIX 1® 41.6 g of powder and 14.4 g of liquid T040140G
GENTAFIX 3® 41.6 g of powder and 14.4 g of liquid T040340G

Bibliography

Wahlig, H. and E. Dingeldein (1980). « Antibiotics and bone cements. Experimental and clinical long-term observations. » Acta Orthop Scand 51(1): 49-56.
Lindberg, L., R. Onnerfalt, et al. (1991). « The release of gentamicin after total hip replacement using low or high viscosity bone cement. A prospective, randomized study. » Int Orthop 15(4): 305-9.
Jiranek, W. A., A. D. Hanssen, et al. (2006). « Antibiotic-loaded bone cement for infection prophylaxis in total joint replacement. » J Bone Joint Surg Am 88(11): 2487-500.
Block, J. E. and H. A. Stubbs (2005). « Reducing the risk of deep wound infection in primary joint arthroplasty with antibiotic bone cement. » Orthopedics 28(11): 1334-45.